Female incontinence control device actuated by abdominal pressure

ABSTRACT

A surgeon-implantable, fluid-filled, flexible device for automatically controlling stress incontinence in female patients employs a flexible diaphragm element positioned in the patient&#39;s abdominal space to compress in response to increases in intraabdominal pressure. Upon such compression of the diaphragm, pressurized fluid flows therefrom via a flexible tubing, optionally via a flow control element, to an inflatable urethra-constricting element in fluid communication therewith and positioned over the patient&#39;s urethra close to her bladder neck. Thus, when the patient experiences an increase in intraabdominal pressure, e.g., when she coughs, fluid from the diaphragm flows rapidly to the urethra-constricting element which presses against and forcibly constricts the urethra adjacent thereto. Upon abatement of the intraabdominal pressure, the flow control element releases fluid from the urethra-constricting element which then ceases to press on the urethra.

FIELD OF THE INVENTION

This invention relates to apparatus and a method for controlling femalestress-induced incontinence. More particularly, it relates to apparatusprovided within a female user to respond automatically to constrict theuser's urethra in response to an increase in abdominal pressure.

BACKGROUND OF THE RELATED ART

Incontinence, i.e., uncontrolled release of urine from the bladder, hasbeen noticed as a condition affecting a growing segment of the femalepopulation in the United States. It is believed that, in the U.S.,approximately 40% of community-dwelling females over 60 years of agesuffer from urinary incontinence that is felt to be socially disabling.See J. Urol., vol. 136, p. 1022, 1986. This also has a huge economicimpact on society. A recent estimate of the annual direct costs ofcaring for persons of all ages with incontinence is about $11.2 billionin the community and about $5.2 billion in nursing homes (based on 1994dollars). See Geriatric Nephrol. Urol., v. 4, pp.85-91, 1994.

The problems of incontinence in females can be broadly grouped into oneof two categories. The first category is one where the incontinence isdue to involuntary contraction of the bladder (or detrusor) muscle. Sucha condition is sometimes termed "an unstable bladder." The secondcategory is the more common one and comprises stress-inducedincontinence, which is best understood as involuntary loss of urineoccurring in correspondence with an increase in the female's abdominalpressure, e.g., during a sudden bout of coughing.

Over one hundred surgical/operational procedures, aimed at controllingor obstructing urine flow through the female urethra, have been proposedto alleviate this common problem. The fact that there are so manydifferent surgical procedures proposed is evidence that no singleoperation has been successful in correcting this condition.

Several devices offering alternatives to surgery are commerciallyavailable to provide temporary relief from the problem of femaleincontinence. These include, for example, the "Artificial UrinarySphincter", marketed by American Medical Systems; the "Reliance"(intra-urethral plug) and the "Impress" (external urethral patch), bothmarketed by Uromed; and the "Capture" (also an external urethral patch)marketed by Bard Urologic.

The "Artificial Urinary Sphincter" comprises an inflatable cuff, whichis a surgically implanted device which encircles the user's urethra. Thecuff is manually deflatable by actuation of a finger-actuated pumpplaced in the user's labia majora. There are, however, certainlimitations in the use of such a device. For example, the cuff isrelatively large and cumbersome to install surgically as it requiresdissection around the proximal urethra to allow placement of the cuffbetween the posterior urethra and the anterior vaginal wall.Furthermore, the pump and release mechanism often cannot be comfortablyplaced in the user's labia majora. During use, this device requires theuser's urethra to be continuously obstructed via the inflated cuff andhas to be manually released by compressing the pump when voiding isdesired. Such devices also have significant technical failure rates. SeeJ. Urol., vol. 136, p.778, 1987. For these reasons, the artificialsplincter is rarely implanted in female patients with stressincontinence.

The "Reliance" device is an internal urethra plug which must be insertedby the user into her urethra. Following the insertion, the user employsa syringe to inflate a small balloon at the distal portion of the devicewhich rests at the neck of the user's bladder to thereby obstruct urineflow. When the user needs to void she has to pull on a string at thelevel of the external urethral meatus which deflates the balloon andpermits the user to withdraw the device. A major drawback of such adevice is that it is designed to be used as a disposable single-useproduct. The typical user thus requires numerous devices every day andincurs significant expense. In addition, the device is a temporarilyplaced, and frequently replaced, foreign body located in a highlysensitive region of the urethra and this may pre-dispose her to urinarytract infections and urethral irritation.

The "Impress" is an external patch which is placed over the opening ofthe urethra by the user and is held in place by an adhesive. When theuser wishes to empty her bladder, she must remove the patch and mustreplace it with a new patch after voiding. One of the major drawbacks ofsuch a device is leakage of urine around the patch because ofinsufficient adhesion. In addition, it also has the limitation of beinga single-use disposable product, which requires the user to carry anumber of the devices with her and incurs significant expense.

The "Capture" is another external device, which is also placed over theopening of the urethra. This device is marketed by Bard Urologic and issomewhat similar to the "Impress" device but remains in place via asuction created during placement of the device. The limitations of sucha device include ineffective fixation on to the external urethra, cost,and incovenience due to it's being a single-use disposable product.

As previously mentioned, over a hundred surgical operations have beendescribed to correct female stress incontinence. These operations areaimed at elevating and/or stabilizing the urethrovesical junction orpartially obstructing the urethra. Since so many operations have beendescribed, obviously no single operation has been successful incompletely eradicating this condition. The difficulty revolves aroundthe fact that there is no standard technique for determining the amountof tension to be placed on sutures or sling material. Also, significantcomplication rates have been reported. See "Clinical Practice Guidelinesfor Urinary Incontinence in Adults: Acute, and Chronic Management", No.2, 1996 Update, pp. 53-59, published by the U.S. Dept. of Health andHuman Services, Agency for Health Care Policy and Research.

Accordingly, there is a present and significant need for a device and amethod of providing protection against the inconvenience ofstress-induced incontinence which would be automatically actuated onlywhen the female user experiences a rise in abdominal pressure, ofsufficient magnitude to produce leakage.

SUMMARY OF THE INVENTION

Accordingly, a principal object of this invention is to provide a devicewhich can be implanted into a female user to apply constriction to herurethra at an optimum location automatically, i.e., without voluntaryaction on her part, whenever she experiences elevated abdominalpressure, with the constriction being automatically released when theabdominal pressure is relieved.

A related object of this invention is to provide an internally containeddevice wearable by a female user to prevent involuntary incontinenceunder circumstances which cause her to experience elevated abdominalpressure.

Yet another object of this invention is to provide an internally worndevice which protects a female user against stress-induced incontinence,the device being capable of automatically acting to constrict herurethra whenever she suffers elevated abdominal pressure andautomatically acts to gradually release control over the urethra whenthe abdominal pressure abates.

It is an even further object of this invention to provide a method bywhich a female user can employ an internally worn device toautomatically constrict her urethra to prevent stress-inducedincontinence in a manner such that control over the urethra is releasedwithout action on her part when her abdominal pressure abates.

It is a related object of this invention to provide a method by which afemale user may internally wear a device in such a manner as toautomatically constrict her urethra to prevent stress-inducedincontinence and gradually release control over the urethra whenincontinence-inducing stress abates.

These and other related objects of this invention are realized byproviding an apparatus for controlling female incontinence, whichcomprises an inflatable element compressible in response to ambientpressure increase and having a first opening, a length of flexibletubing communicating at a first end with an interior of the inflatableelement via said first opening, and a urethra-constricting element whichhas an inflatable portion with a second opening communicating with asecond end of said flexible tubing.

In another aspect of this invention there is provided a method forpreventing stress-induced incontinence, comprising the steps of forminga small transverse skin incision above the symphysis pubis of a femalepatient and then entering the patient's retropubic space in known mannerand identifying an anatomic location of the bladder neck of the patient.This is followed by the step of fixing to the patient's vagina, onopposite sides of the proximal urethra and bladder neck, aurethra-constricting element comprising an inflatable portioncommunicating with one end of a length of flexible tubing; and, incommunication with another end of said tubing, providing an inflatableelement that is compressible in response to ambient pressure increaseand is placed at a selected location in the abdomen such that when theinflatable element is subjected to an increase in intraabdominalpressure it will compress to transfer a fluid via said tubing to expandthe inflatable portion of the urethra-constricting element against animmediately adjacent portion of the urethra to thereby squeeze andlocally constrict the urethra.

In yet another aspect of this invention, there is provided a method ofcontrolling female incontinence, which includes the steps ofinsufflating a female patient's abdomen with carbon dioxide, forming asharp or blunt entrance into the patient's retropubic space withlaparoscopic scissors or any other known instrument, and identifying thepatient's bladder neck. This is followed by the step of placing in theretropubic space an inflatable element communicating via a flexibletubing with a urethra-constricting element having an inflatable portionpositioned over a selected portion of the patient's urethra, whereby anincrease in the patient's abdominal pressure will cause compression ofthe inflatable element, transmission of pressure via the tubing, and acorresponding expansion of the inflatable portion of theurethra-constricting element to press against an adjacent portion of thepatient's urethra and squeeze the same to impede urine flowtherethrough.

BRIEF DESCRIPTION OF THE DRAWING

FIG. 1 is a perspective view of a first preferred embodiment of thisinvention.

FIG. 2A is a transverse cross-sectional view of a controllablyinflatable, flexible, pressure-responsive, diaphragm component of theapparatus at Section IIA--IIA in the first embodiment per FIG. 1, in arelatively inflated state; and FIG. 2B is a side elevation view of thesame diaphragm component in a relatively inflated state.

FIG. 3A is a first perspective view of an exemplary inflatableurethra-compressing component, fitted to a substantially planar base, inthe device according to the first embodiment per FIG. 1; FIG. 3B is aperspective view of the same urethra-compressing component from anopposite side; and FIG. 3C is a cross-sectional view at SectionIIIC--IIIC in FIG. 3A.

FIG. 4A is a schematic transverse cross-sectional view of theurethra-constricting component per FIGS. 3A--3C, in installed positionrelative to an optimum location on the urethra, in an uninflated state;and FIG. 4B is a similar view of the same device when it is inflated toconstrict the urethra.

FIG. 5 is a partial perspective view of a second preferred embodiment ofthe invention, generally similar to the first preferred embodiment butalso including a flow-modulating component.

FIG. 6 is a transverse cross-sectional view, at Section VI--VI, of theflow-modulating component of the second embodiment per FIG. 5.

FIG. 7 is a cross-sectional view of a diaphragm provided with anexpansion element.

FIG. 8 is a perspective view of an alternative, non-planar, form of abase portion of the urethra-constricting element.

FIG. 9A is a perspective view of yet another non-planar base portion ofthe urethra-constricting element; and FIG. 9B is an end view of theurethra-constricting element per FIG. 9A fitted with an elasticallyexpandable element for applying a constricting force to the urethra.

FIG. 10A is an upward perspective view of a modification of theurethra-constricting element base shown in FIG. 8, comprising aforce-concentrating flexible base extension;

FIG. 10B is a partially-sectioned end view thereof with the flexibleportion in an uninflated rest position; and FIG. 10C is a similar viewwith the flexible portion in an inflated position.

FIG. 11 shows a view of a patient's surgically exposed abdomen with anincontinence device emplaced in accordance with an embodiment of thepresent invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

As best seen in FIG. 1, in a first preferred embodiment of thisinvention there is provided an incontinence control device 100 whichcomprises at a first end a flexible, pressure-sensitive, hollow,diaphragm component 102 having a deformable interior space.

As best seen in FIG. 2(A), diaphragm 102 is most conveniently formed oftwo flexible sheet-like elements 104 and 106 adhered around theirrespective annular portions to each other. A substantial portion of thecentral area of each of elements 104 and 106 is left unadhered to theother, so that when a biocompatible fluid 200 is provided therein thereis formed a space of variable volume filled with the fluid 200.

The material of which elements 104 and 106 are made is chosen fromwell-known flexible, durable, sterilizable, biocompatible materials.These typically are plastics materials which can be sterilized inconventional manner, e.g., in an autoclave or otherwise during or aftermanufacture, are relatively inexpensive, and can be securely adhered toeach other with conventional adherent materials or heat-seamed to eachother by the application of a localized high temperature in knownmanner. The exact compositions of these materials, and the ways in whichthey may be joined or adhered to each other, are not critical to thisinvention and any conventional technique may be employed to form thestructure of diaphragm 102.

Diaphragm 102 communicates at an opening 108 with a first end of aflexible, biocompatible tubing 110 which may be of an overall lengthselected by the prescribing surgeon, i.e., this is an element having alongitudinal dimension customized to suit the user. In the alternative,the device 100 can be made in modular fashion, for example with variouslengths of the flexible tubing element 110, so that a prescribingsurgeon may simply select the structure most appropriate for aparticular patient.

At the other end of flexible tubing 110, and in fluid communicationtherewith, there is provided a urethra-constricting unit 112 having asubstantially rigid base 114 which may be but is not necessarily flat.Base 114 is preferably provided with a plurality of through-holes 116close to its edges, preferably near its corners if it is selected to beof a substantially rectangular shape. It is not necessary that it be ofrectangular shape, have a specific number of through-holes 116, or havea specific thickness. These are all matters of design choice. What isimportant is that base 114 be made of a size and shape suitable forsecure long-term affixation by known means to the user's tissue asdescribed below.

As best seen in FIG. 2A, an exemplary diaphragm 102 may be of twocooperating flexible elements 104 and 106 connected to each other in aperipheral annular interface region, so that a substantially centralportion may be flexibly spaced-apart by increasing the amount of a fluid200 contained in the space therebetween. Obviously, using suitablemanufacturing techniques, such a component may be made to have a unitarystructure, e.g., like a bladder having a single opening at which itcommunicates with a proximal end of tubing 110. The fluid 200 should bea sterile, biocompatible liquid, e.g., a saline solution, which can dono harm to the patient in the event of a system rupture leading touncontrolled release of the fluid into the patient's abdomen.

For certain applications, e.g., when the surgeon concludes that thepatient would be best served by laparoscopic implantation of the device,it may be appropriate to fill the device with a suitable fluid after itis implanted as desired. In such a procedure all of the principalelements, i.e., diaphragm 102, tubing 110 and urethra-constrictingelement 114, are made of flexible materials so that each can be rolledtight to be introduced into the patient's abdominal cavity via asuitable tubular cannula. Then, with the use of conventionallaparoscopic forceps, and/or other known tools, the elements may bereadily assembled within the patient's abdominal cavity.

To be operational, the system then must be filled with a suitable amountof fluid. To facilitate this step, an additional cannula-insertablevalve element 120, e.g., of a kind known for use with intravenoustubing, may be connected to two segments of flexible tubing 110 as bestseen in FIG. 1. An example of such a known and commercially availableinjection valve element is QUOSINA Model No. 84040. Once the assembly iscomplete, the surgeon forcibly inserts a hypodermic needle into valve120, via a resilient seal element 122 thereof, to inject the fluid. Uponwithdrawal of the needle the seal element closes up and the fluid isthereafter retained within the apparatus to perform its intendedfunction.

FIG. 2B shows diaphragm 102 in side elevation view when it containssufficient fluid 200 to cause a substantial distention of thefluid-containing space defined therein. As will be understood by personsof ordinary skill in the mechanical arts, a selected amount of fluid 200must be present within diaphragm 102 to cause the substantially centralportions of flexible portions 104 and 106 to be spaced-apart from eachother to define a relatively large central volume, e.g., in the regionhaving diameter "D₁ ". As described below with reference to FIG. 7, aninternal element may be included to ensure an outward biasing force toensure such spaced-apart central disposition of flexible elements 104and 106.

When there is a sufficient amount of fluid 200 contained withindiaphragm 102, the substantially central portions of flexible portions104 and 106 will be well spaced-apart and together will present arelatively large external surface area subjected to ambient externalpressure changes on both sides. There will be corresponding pressurechanges felt by the fluid 200 contained within diaphragm 102 and theflexible tubing 110 and urethra-constricting component 112 that are influid communication with each other.

Any pressure increase felt from the ambient surroundings of diaphragm102 located in the abdominal cavity where it will experience pressurechanges, e.g., if the patient coughs, will cause it to be compressed. Acorresponding expulsion of a pressurized outward flow of fluid will thenbe rapidly communicated via flexible tubing element 110 from thediaphragm 102 to cause some fluid from the tubing element 110 to enterinto urethra-constricting element 112.

The amount of fluid to be placed in the containment space defined withinthe diaphragm 102, flexible tubing 110 and inflatableurethra-constricting element 112 can be pre-operatively determined byperforming an abdominal leak point pressure test on the patient. Thistest can quantitate exactly how much abdominal pressure is required toproduce leakage in a particular patient, hence on the basis ofexperience and empirical data the device can be reliably customized bythe surgeon to suit the patient's specific needs.

The exact shape of diaphragm 102 is not critical to this invention,i.e., it need not be circular and may even be of irregular shape ifdeemed advantageous.

As best seen in FIG. 3A, urethra-constricting element 112 has a base 114provided with a plurality of through-holes 116. To one side of base 114,as best seen in FIG. 3B, is connected a flexible compartment 118 whichcommunicates with flexible tubing 110. As best seen in FIG. 3C, thefluid contained within diaphragm element 102 can communicate anypressure changes through the fluid contained in flexible tubing 110 tothe fluid contained within flexible compartment 118. Therefore, when theuser's abdominal pressure acting on diaphragm 102 increases, the effectwill be transmitted via a corresponding pressurized flow of fluid 200contained within tubing 110 to the fluid contained in flexibleurethra-constricting chamber 118 and this will cause the latter toexpand in volume.

The material of which base 114 is made, as well as the material of whichflexible chamber 118 is made, are matters of design choice. What isrequired is that these materials be sterilizable and biocompatible overextended periods. Numerous such materials are known and are commerciallyused in implant structures, and the specific choice is not critical tothe success of this invention.

As best seen in FIG. 4A, in its operational position theurethra-constricting element 112 is preferably sutured via through-holes116, or otherwise securely disposed, over a selected portion of tissue450 close to the female user's urethra 400. Sutures 402, 402 passingthrough through-holes 116, 116 preferably anchor theurethra-constricting component 112, as shown in FIGS. 4A and 4B, to theuser's anterior vaginal wall and/or to the symphysis pubis 404. Otherknown alternatives such as clips, staples, screws (into bone), or evenselected adhesives may be employed to affix urethra-constricting element112 in place. See also FIG. 11.

Urethra-constricting element 112 is disposed with its flexible chamber118 in direct contact with that portion of urethra 400 which is to bepressured and forcibly deformed in response to the fluid flow underpressure transmitted via tubing 110. FIG. 4B schematically illustrates asituation in which, due to a rise in abdominal pressure, as when thefemale user of the device coughs or sneezes, there is a temporary butswift rise in abdominal pressure experienced by fluid 200 contained indiaphragm element 102. This will lead to pressurized flow of fluid 200from diaphragm 102 via flexible tubing 110 to the interior of flexiblechamber 118 which will correspondingly expand in volume. The portion offlexible chamber 118 which is in direct contact with urethra 400 willthus be inflated and forced to move away from anchored base 114 andtoward the urethra so as to squeeze and forcibly close it to preventflow of urine therethrough.

In simple terms, therefore, when the user of device 100 experiences anincrease in abdominal pressure during a natural activity such ascoughing or sneezing, she will not experience consequential involuntarystress-incontinence. Instead, the increase in her abdominal pressurewill automatically squeeze out some of the fluid 200 contained withindiaphragm 102 and send it via flexible tubing 110 to the interior ofchamber 118 which will then expand in volume and immediately compressurethra 400 to prevent expulsion of urine from the user's bladder.

The benefits of the first embodiment of this invention may be readilysummarized as follows: depending on the age and physical size of thepatient, the surgeon installing the first preferred embodiment 100 willselect a diaphragm 102 of suitable size, preferably from a modular setof the same. The surgeon will then ensure that there is a suitablelength of flexible tubing 110 communicating therewith and with aurethra-constricting element 112 attached, as shown in FIG. 1, with apredetermined quantity of biocompatible fluid 200 filled in. The surgeonwill then insert the flexible pressure-sensitive diaphragm into thepatient/user's abdomen where it will readily experience changes inambient abdominal pressure.

If a laparoscopic procedure is selected, the elements will be introducedinto patient's abdomen via a cannula, located in assembly with eachother, and inflated with a predetermined amount of selected fluid asdescribed earlier.

As will be appreciated, it is important that a sudden increase in thepatient's abdominal pressure be communicated rapidly to theurethra-constricting element 112 to cause it to promptly constrict theadjacent portion of the urethra 400, i.e., cause it to go from the stateshown in FIG. 4A to the state shown in FIG. 4B. Delay in this action maypermit leakage of urine and is to be avoided. On the other hand, it ishighly desirable that abatement of the pressure increase not result inan immediate cessation of the closing force being applied to the urethraby urethra-constricting element 112. In other words, it is desirable toprovide a mechanism for imposing a time-delay in the release of theconstricting force applied to the urethra, so that any residual pressurestill experienced by the bladder is not caused to result in involuntaryleakage of urine.

FIG. 5, in schematic form, indicates how a small flow-control element600 may be included in the system described above. The system as shownin FIG. 5 includes both flow-control element 600 and fluid-injectionvalve element 120. Persons of ordinary skill in the art will appreciatethat either or both of these elements may be included in the system asdesired.

As best seen in transverse cross-sectional view per FIG. 6, flow-controlelement 600 in exemplary form preferably include a loop-channel 602communicating at one point with a portion 110a of the flexible tubingconnected to diaphragm 102 and, on an opposite side of flow-controlelement 600, to a length of tubing 110b connected tourethra-constricting element 112.

Loop 602 preferably has a first branch 604 provided with a one-way valvestructure 606 such that flow of fluid is permitted only in the directionof arrow "A", i.e., only from diaphragm 102 toward urethra-constrictingelement 112. Loop 602 also includes a second branch 606 provided with acarefully-calibrated flow-limiting, small-bore, flow-impedance portion608. In principle, the fluid can flow through flow-impedance portion 608in both directions, but can do so only at a selected relatively slowflow rate in direction "B".

Flow valve element 606 may comprise, as illustrated in FIG. 6, a conicalportion of branch 604, a ball 610, and a helical biasing spring 612which tends to apply a biasing force to resiliently hold ball 610 in theconical portion of branch 604 to keep it closed. Then, when pressure onthe diaphragm side increases sufficiently, the biasing force of spring612 will be overcome, ball 610 will be forcibly moved out of place, andfluid can flow past the ball so long as a sufficient pressure isavailable. Some fluid will simultaneously also flow through small-boreflow-impedance portion 608 of the opposite branch 606. The combined flowof fluid will thus flow through both branches 604 and 606 into theurethra-constricting element 112 in direction "A" whenever there is asignificant increase in abdominal pressure.

When the abdominal pressure abates, there will be a tendency for fluidfrom the urethra-constricting element to flow via tubing 110b backthrough flow control element 600 into diaphragm 102. Upon the abatementof abdominal pressure, spring 612 and ball 610 will cooperate to sealoff branch 604 of loop 602. Return flow, in direction B, can now takeplace solely through small-bore flow-impedance portion 608 of branch 606of loop 602.

The flow-impedance provided by impedance portion 608 is a matter ofdesign choice, and by appropriate dimensioning it can be expected toslow down release of the force applied to previously constrict urethra400 for a selected length of time, e.g., by a few seconds. With theprovision of such a flow-control element 600, therefore, the system willact promptly in response to sudden increases in abdominal pressure toclose off the patients's urethra but, upon the abatement of such apressure, will take a few seconds to totally remove the force applied tothe urethra.

It is desirable that upon the abatement of ambient abdominal pressurediaphragm 102 be refilled with fluid flowing back via tubing 110 fromthe urethra-constricting element 112. FIG. 7 in the cross-sectional viewshows a modified form of the diaphragm element. In this embodiment,diaphragm 700 is formed of two elements 702 and 704 adhered to eachother at their respective annular edge portions, with one end of alength of flexible tubing 110 fitted therebetween. Elements 702 and 704are formed to have internal rims 706 and 708 which oppose each other andcooperatively locate opposite ends of a small internal biasing spring710. Spring 710 may be made of any suitable material and should be sizedto provide a gentle outwardly biasing force sufficient to cause thecentral portions of elements 702 and 704 to move away from each otherwhen abdominal pressure abates.

The exact dimensioning, choice of materials, thickness of spring 710,etc., are all considered design details which persons in the ordinaryskill in the mechanical arts should be able to select in light of thepatient's needs.

With such a diaphragm 700, an increase in abdominal pressure acting overthe relatively large external surface areas of elements 702 and 704 willcause compression of spring 701 and movement of the central portions ofelements 702 and 704 towards each other. The resulting expulsion ofpressurized fluid via flexible tubing 110 towards theurethra-constricting element should effect the desiredurethra-constriction. Upon abatement of the external pressure spring 710will expand outward and there will be a reduced pressure insidediaphragm 700. This will cause a return flow of the fluid back from theurethra-constricting element 102. The provision of a flow-controlelement 600 in such a system will cause the return flow to be relativelyslow.

As mentioned earlier, it is not necessary that base 114 ofurethra-constricting element 112 be flat. FIG. 8 illustrates analternative form 600 of such a base. It comprises two substantialco-planar fixation portions 802 and 804, each provided with a pluralityof apertures 806. A central recessed portion 808 is suitably sized toprovide accommodation for fluid-receiving, flexible, expandable portion810 of urethra-constricting element 800. This flexible expandableportion is in combination with flexible tubing 110 to receivepressurized fluid from the diaphragm (not shown) during use. Dependingon the patient's personal circumstances, such an element may bepreferable to the element 112 discussed earlier with particularreference to FIGS. 3A and 3B.

FIG. 9A illustrates in perspective view yet another alternative.Urethra-constricting element 900 has a base comprising two substantiallyco-planar portions 902, 904 provided with respective through apertures906, with a central recessed portion defining a semi-cylindrical space908 for accommodating the expandable portion 910 of theurethra-constricting element 900.

For certain patients, it may be desirable to form thepressure-responsive expandable portion 910 of an elastic material of athickness and elasticity such that when the system is not subjected toambient abdominal pressure it shrinks to a relatively small size easilycontained within space 908, as best seen in FIG. 9B. Then, whenabdominal pressure increases sufficiently to cause flow of pressurizedflow via tubing 110, the elastic portion 910 will stretch and expand, asindicated by the broken lines in FIG. 9B, to take on an enlarged form912. In this embodiment, the expandable portion 910 of theurethra-constricting element is not just flexible but is alsoelastically expandable. This elasticity inherently ensures that as soonas the abdominal pressure abates there will be an inherent tendency forelastic element 910 to return to its non-stretched shape and size and toreturn previously received fluid back to the diaphragm.

As persons of ordinary skill in the mechanical arts will readilyappreciate, it may be desirable to provide a diaphragm 700 having aninternal biasing spring 710, as discussed above with reference to FIG.7, as well as an elastically stretchable portion 910 as illustrated anddiscussed above with reference to FIG. 9B. These two features, combinedwith a flow-control element 600 as discussed above with reference toFIGS. 5 and 6, should provide a responsive and highly effectivecontinence-control system.

For certain patients it may be necessary to apply a significant localforce to constrict the patient's urethra sufficiently. FIG. 10A inperspective form illustrates a form of base 1000 provided with atransverse, substantially central, elastic cantilever tongue 1002pressing against the expandable portion 1004 which is to expand inresponse to an increase in abdominal pressure.

As best seen with joint reference to FIGS. 10B and 10C, with such astructure the elastic tongue 1002 will press expandable portion 1004against an inside surface of the base of the urethra-constrictingelement so as to force out therefrom some or all of the fluid initiallypresent therein. This should be the situation when there is no increasedabdominal pressure being experienced by the patient. Then, when there isan increase in the patient's abdominal pressure, and the diaphragmelement of the system is compressed to force a corresponding flow offluid through flexible tubing 110, entry of that pressurized fluid intothe expandable/elastic portion 1004 will cause it to expand against thebiasing force of tongue 1002. This is best seen in FIG. 10C.

As reference to FIG. 10A we will now make clear, the surface area oftongue 1002 that will press against urethra 400 can be madesignificantly smaller than the surface area of flexible/elastic portion1004 which otherwise would have pressed on urethra 400 in an attempt toconstrict the same. Thus, by reduction of the applied area, aforce-concentration is obtained by which flexible/elastic portion 1004of the urethra-constricting component acts on urethra 400 to close thesame. Such a system may be highly responsive even to relatively smallincreases in abdominal pressure, and may permit the patient to perform awider range of activities while being ensured that problem of stressincontinence will be effectively addressed. This may be important forpatients who wish to perform physical exercises. Such a situation may bedistinguished from the one in which a patient coughs, sneezes, orotherwise undergoes a virtually involuntary act resulting in an increasein abdominal pressure. It can thus be seen that the present invention,by appropriate sizing and selection of optional features, can be readilyadapted to meet a variety of needs.

One preferred surgical procedure for implanting the device involves theformation of a transverse or mid-line incision in the lower abdominalarea of the patient, to permit access into the patient's retropubicspace. Following the initial incision, the surgeon incises the tissueand the anterior rectus facia. The rectus muscles are then separated inthe mid-line, and a further sharp or blunt dissection allows access tothe retropubic space 1100 or space of retzius. See FIG. 11. A Foleycatheter positioned in the patient's bladder 1102 with a largeinflatable balloon 1104 provided at the distal end thereof can beemployed for easy identification of the bladder neck or urethrovesicaljunction by simple palpation by a finger of the surgeon's hand 1106inserted vaginally. The urethra-constricting element 112 of theapparatus is then placed over the anterior surface of the proximalurethra 400 just below the bladder neck. It is then fixed to themuscular portion of the vaginal wall 1108 on opposite sides of thebladder neck, and may also optionally be affixed to the back of thesymphysis pubis 1110. The urethra-constricting element 112 is thenconnected via flexible tubing 102 to the fluid-filled diaphragm 102 (orany of its variations) which is located in an intra-abdominal positionwhere it can experience changes in abdominal pressure. The diaphragm 102may be located in close proximity to the bladder 1102 and, if desired,may be fixed in position by suturing into surrounding tissue or by anyother method of fixation.

Once the device has been appropriately located and affixed, it should betested intra-operatively by applying a pressure on the diaphragm 102 tomake certain that the urethra-constricting element 112 respondsappropriately. If a flow-control element 600 has been included in thesystem, the surgeon at this stage should make certain that flows inopposite directions, per arrows "A" and "B" in FIG. 6, are as intended.

An endoscopic evaluation of the patient at this time would also beadvantageous. Urethroscopy is performed to look at the urethra 400 fromthe inside to make certain that the urethra-constricting element 112 isappropriately located and acting when the device is actuated. Also, atthis time, a cystoscopy may be performed to view the inside of thebladder 1102 and make certain that no inadvertent injury has occurred,that there is no inadvertent suture penetration, and that both uretersare functional.

If the laparoscopic surgery option has been selected, the necessarylaparascopic insertion to obtaining access to the patient's retropubicspace can be performed in known manner, e.g., laparoscopy withinsufflation of the patient's abdominal cavity with carbon dioxide andsharp dissection into the retropubic space via a transperitonealapproach. In the alternative, an extra-peritoneal approach may beutilized, using either a conventional commercially availableinsufflation balloon or any other known technique to obtain access tothe retro pubic space. Other techniques, e.g., utilizing a gaslessapproach or other insufflation media may also be considered and used asappropriate.

Once the retropubic space has been accessed, the surgeon may employ aFoley catheter in the patient's bladder to determine the preciselocation of the urethrovesicular junction or urethra where theurethra-constricting element is to be located.

As noted earlier, when the laparascopic option is selected, the variouselements may have to be initially rolled or folded tightly uponthemselves so that each occupies a relatively small space and can beinserted via appropriately sized and located cannulae. The surgeon maynormally position more than one cannula, and one of these may be used.The inserted elements are then connected to each other by suitablelengths of the flexible tubing 110, and the urethra-constricting element112 (or any of the other options as discussed above) is then affixed tothe vaginal tissue 1110 on opposite sides of the urethra 400 exactly asin the open incision technique. The surgeon may employ suturing clips,sutures 402, or any other elements for this purpose. Theurethra-constricting element, in the alternative, may be affixed byclips, screws or the like to the symphysis pubis 1100. The diaphragm 102and the flexible tubing 110, also passed through a suitable cannula, arethen connected as discussed above. The inside space of the apparatus isthen filled with the selected fluid via the injection valve component120.

In order to determine exactly how much fluid to supply to the system,the surgeon may perform preliminary experiments with the patient todetermine her normal intraabdominal pressure. The surgeon may then askthe patient to cough while her urethra is constricted by pressureapplied digitally by the surgeon through the patient's vagina.

As will be readily appreciated by persons skilled in the type ofspecialized surgery involved, a certain degree of experience andjudgment must guide the surgeon's decision on the length of flexibletubing 110, the manner of fixation of diaphragm 102 andurethra-constricting element 112, the amount of fluid to be filled in,whether to use open incision surgery or laparascopic surgery, andnumerous other related factors.

Accordingly, a more precise specification of such details for presentpurposes is not deemed necessary .

With regard to the method according to this invention, as persons ofordinary skill in the mechanical and electro-mechanical arts andexperienced in implantable devices will appreciate, the key is to sensean increase in intraabdominal pressure and to quickly apply a pressureto the urethra to thereby locally constrict it and prevent any leakageof urine. Obviously, apparatus to exercise the necessary detection ofpressure and to generate the corresponding local force to temporarilyconstrict the urethra need not be solely mechanical, nor does it have torely solely on hydrostatic principles. It is therefore to be understoodthat alternative elements of apparatus, including for examplepiezoelectric sensors/switches, electrical relays, electromagneticsolenoids to generate force, etc., may be adapted and substituted forthe above-discussed exemplary elements in order to practice the methodin its various aspects.

Obvious modifications and variations of the above-described structureand the manner of its use will no doubt occur to persons of ordinaryskill in the art. All such obvious modifications and variations areintended to be comprehended within the present invention which islimited solely by the claims appended below.

What is claimed is:
 1. An entirely implantable apparatus for controllingincontinence in a female, comprising:an inflatable element formed toautomatically compress in response to an intraabdominal pressureincrease during use and having a first opening; a length of flexibletubing, communicating at a first end with an interior of the inflatableelement via said first opening; and a urethra-constricting element,comprising an inflatable portion having a second opening communicatingwith a second end of said flexible tubing, whereby said increase inintraabdominal pressure will inflate the inflatable portion against saidfemale's urethra to automatically constrict the same.
 2. The apparatusaccording to claim 1, further comprising:an injection valvecommunicating with the interior of the inflatable element, having asealing portion formed to receive fluid via a hypodermic needle and toautomatically seal when the hypodermic needle is removed.
 3. Theapparatus according to claim 2, further comprising:a predeterminedquantity of a selected fluid, contained within the inflatable element,the flexible tubing and the urethra-constricting element.
 4. Theapparatus according to claim 3, further comprising:a flow controlelement connected to the flexible tubing to selectively control flow ofthe fluid at a first rate in a first direction from the inflatableelement to the urethra-constricting element and at a second rate in asecond direction from the urethra-constricting element to the inflatableelement.
 5. The apparatus according to claim 2, wherein:theurethra-constricting element comprises a securing portion formed to beinternally secured adjacent a selected portion of a user's urethra withthe inflatable portion thereby disposed to press against and squeeze theurethra when inflated.
 6. The apparatus according to claim 5, furthercomprising:a predetermined quantity of a fluid, contained within theinflatable portion, the flexible tubing and the urethra-constrictingelement.
 7. The apparatus according to claim 6, wherein:the inflatableelement is formed so that, in a deflated state, it can be rolled into asmall cylindrical shape laparoscopically insertable into a user'sabdominal cavity.
 8. The apparatus according to claim 2, wherein:theurethra-constricting element comprises an elastic element locatablebetween the patient'urethra and the inflatable portion.
 9. The apparatusaccording to claim 1, further comprising:a predetermined quantity of aselected fluid, contained within the inflatable element, the flexibletubing, and the urethra-constricting element.
 10. The apparatusaccording to claim 9, wherein:the selected fluid is a sterilebiocompatible liquid.
 11. The apparatus according to claim 10,wherein:the liquid is a saline solution.
 12. The apparatus according toclaim 9, further comprising:a flow control element connected to theflexible tubing to selectively control flow of the fluid at a first ratein a first direction from the inflatable element to theurethra-constricting element and at a second rate in a second directionfrom the urethra-constricting element to the inflatable element.
 13. Theapparatus according to claim 1, wherein:the inflatable element includesan element providing a biasing action for resisting compression of theinflatable element due to said intraabdominal pressure increase.
 14. Theapparatus according to claim 1, wherein:the urethra-constricting elementcomprises a securing portion formed to be internally secured adjacent aselected portion of a user's urethra with the inflatable portion therebydisposed to press against and squeeze the urethra when inflated.
 15. Theapparatus according to claim 14, wherein:the securing portion of theurethra-constricting element comprises a biasing element acting to biasthe inflatable portion to an uninflated state.
 16. The apparatusaccording to claim 14, further comprising:means for securing theurethra-constricting element on opposite sides of the user's proximalurethra.
 17. The apparatus according to claim 1, wherein:the inflatableportion is elastically expandable.
 18. The apparatus according to claim1, wherein:the inflatable element is formed so that, in a deflatedstate, it can be rolled into a small cylindrical shape laparoscopicallyinsertable into a user's abdominal cavity.
 19. The apparatus accordingto claim 18, wherein:the securing portion of the urethra-constrictingelement comprises a biasing element acting to bias the inflatableportion to an uninflated state.
 20. The apparatus according to claim 18,wherein:the inflatable portion is elastically expandable.
 21. Theapparatus according to claim 1, wherein:the urethra-constricting elementcomprises an elastic element locatable between the patient's urethra andthe inflatable portion.
 22. A method of controlling female incontinence,comprising the steps of:forming an abdominal skin incision above thesymphysis pubis of a female patient; entering the patient's retropubicspace through the incision and identifying an anatomic location of theuser's bladder neck; fixing, on opposite sides of the proximal urethraand bladder neck, a urethra-constricting element comprising aninflatable portion communicating with one end of a length of flexibletubing; and in communication with another end of said tubing providingan inflatable element that is compressible in response to anintraabdominal pressure increase and is placed at a selected locationsuch that when the inflatable element is subjected to an increase inintraabdominal pressure it will automatically compress to transfer aselected fluid via said tubing to the inflatable portion of theurethra-constricting element to thereby cause the urethra-constrictingelement to expand against an immediately adjacent portion of the urethrato squeeze and constrict the urethra threat.
 23. The method according toclaim 22, comprising the further step of:selectively extracting from oradding to the selected fluid contained within the mutually communicatinginflatable element, flexible tubing and urethra-constricting element,whereby the responsiveness of the urethra-constricting element isadjusted to said patient's particular needs.
 24. The method according toclaim 22, wherein:the urethra-constricting element comprises an elasticelement locatable between the patient's urethra and the inflatableportion.
 25. A method of controlling incontinence in a female patient,comprising the steps of:forming an entrance into the patient'sretropubic space; identifying the patient's bladder neck; and throughthe entrance, locating in the retropubic space a fluid-containinginflatable element communicating via a flexible tubing with aurethra-constricting element having an inflatable portion positionedadjacent a selected portion of the patient's urethra adjacent thebladder neck, whereby an increase in the patient's abdominal pressurewill cause compression of the inflatable element, transmission of apressurized flow of a fluid via the tubing, and a correspondingexpansion of the inflatable portion of the urethra-constricting elementto cause the urethra-constricting element to press against the selectedportion of the patient's urethra and squeeze the same to thereby impedeurine flow therethrough.
 26. The method according to claim 25,wherein:the step of locating the inflatable element comprises the stepsof initially deflating the inflatable element, rolling it tightly into asmall cylindrical form, and introducing it through a cannula to aselected location in the patient's abdomen; and injecting a suitablequantity of the fluid into the inflatable element.
 27. The methodaccording to claim 26, comprising the further step of:securing theurethra-constricting element by affixation thereof to the patient'stissue adjacent the urethra.
 28. The method according to claim 27,wherein:the securing step comprises at least one of suturing to softtissue and affixation to bone.
 29. The method according to claim 25,wherein:the urethra-constricting element comprises an elastic elementlocatable between the patient's urethra and the inflatable portion. 30.A method of controlling female incontinence, comprising the stepsof:sensing an increase in the female's abdominal pressure; communicatingthe increased pressure to a selected location on the female's urethra;and applying the increased pressure to solely thereby constrict thefemale's urethra at the selected location.
 31. A method of controllingfemale incontinence, comprising the step of:placing within the patient'sretropubic space a compressible fluid-filled diaphragm elementcommunicating via a flexible tubing with a urethra-constricting elementhaving an expandable portion positioned adjacent a selected portion ofthe patient's urethra near the patient's bladder neck; whereby anincrease in the patient's abdominal pressure will cause compression ofthe diaphragm element and expulsion therefrom of a corresponding flow offluid via the tubing, and a corresponding expansion of the expandableportion against an adjacent portion of the urethra will thereby squeezeand temporarily constrict the urethra thereat to impede urine flowtherethrough.
 32. The method according to claim 31, comprising thefurther step of:providing an elastic element between the expandableportion and the adjacent portion of the urethra, whereby the expandableportion transmits a force via the elastic element to the adjacentportion of the urethra.